(68 days)
This submission describes a software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.
software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician.
This appears to be a pre-amendment 510(k) summary, or at least a very early one, given the approval date of APR 28, 1997. The level of detail and specific study requirements for 510(k) submissions has evolved significantly since then. Based solely on the provided text, it is not possible to extract the detailed information requested regarding acceptance criteria, specific study designs, or performance metrics.
The provided text is a high-level summary that states:
- Product Name: ImMerge™ Image Correlation System
- Purpose: Provides precise spatial registration of two image sets to enhance imaging information for diagnosis, planning treatments (image-guided surgery, stereotactic radiosurgery, radiotherapy).
- Premarket Submission Type: 510(k) (indicated by "K970623")
- Key Statement: "The ImMerge™ Image Correlation System was shown to be substantially equivalent to other commercially available image correlation systems. Evidence of the substantial equivalence was provided."
This summary indicates that the submission relied on demonstrating substantial equivalence to a predicate device, which was the standard for 510(k)s. However, it does not include the detailed technical and clinical performance data that would typically be found in more recent 510(k) summaries or full submission documents.
Therefore, I cannot provide the requested information. The text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details or effect sizes.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion: The provided text is insufficient to answer the detailed questions about acceptance criteria and study particulars because it is a very brief summary focused on the substantial equivalence declaration rather than performance data. To obtain this information, one would typically need access to the full 510(k) submission documentation, which is generally more extensive than this summary.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).